Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error
Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (unnecessary radiation exposure) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,301 units of the SOMATOM Emotion 16 CT scanner. These devices are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. The recall is due to a potential software defect in the CARE Dose4D algorithm.
The defect may cause incorrect tube current calculations for head scans that use posterior-anterior (p.a.) or anterior-posterior (a.p.) topograms. In rare cases, depending on the geometrical shape of the patient's skull bone, the calculated dose distribution may be inappropriate. This could lead to unnecessary radiation exposure for patients.
The affected units were distributed nationally in the United States. The source text does not specify specific dates, lot numbers, or reported injuries. Healthcare facilities should contact Siemens Medical Solutions for instructions on how to address the software issue.
The recalled product
- Product
- SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 1,301
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 10046789
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 15 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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